NCT01707654

Brief Summary

A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. From July 2008 to May 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. The purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 23, 2013

Completed
Last Updated

November 21, 2018

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

October 12, 2012

Results QC Date

June 3, 2013

Last Update Submit

October 25, 2018

Conditions

Infection WoundDisruption of Nerve Repair

Keywords

defect;dorsal branch of the proper digital nerve;proper digital nerve;finger sensory reconstruction.

Outcome Measures

Primary Outcomes (1)

  • 2-point Discrimination Test

    The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent \<6 mm; good 6-10 mm; fair 11-15 mm; poor \>15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.

    17-25 months

Secondary Outcomes (1)

  • Semmes-Weinstein (SW) Monofilament Test

    17-25 months

Other Outcomes (1)

  • Pain

    17-25 months

Study Arms (1)

nerve graft

OTHER

Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.

Device: Nerve flap

Interventions

Nerve flapDEVICE

Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.

nerve graft

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • an infective wound with exposed bone or tendon in the finger;
  • soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both;
  • associated digital nerve defect 1 to 4 cm in length;
  • single or double nerve defects; and
  • simultaneous repair of nerve and soft tissue defects.

You may not qualify if:

  • injury to the course of the pedicle or the donor site;
  • nerve defect less than 1 cm or larger than 4 cm in length;
  • occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb;
  • no involvement of the digital nerve.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related Publications (2)

  • Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.

    PMID: 20888502RESULT

  • Chen C, Tang P, Zhang L. Use of a bipedicled nerve flap taken from the dorsum of the digit for reconstruction of neurocutaneous defect in the adjacent finger. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1322-9. doi: 10.1016/j.bjps.2013.06.001. Epub 2013 Jul 2.

    PMID: 23829956DERIVED

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

Title
Dr. Chao Chen
Organization
The Second Hospital of Tangshan
ts_chenchao@163.com
86-13700350471

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 16, 2012

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

February 1, 2012

Last Updated

November 21, 2018

Results First Posted

October 23, 2013

Record last verified: 2012-04

Locations

CN(1)